As Dr. Atul Gawande wrote about in the New York Times, a really misguided federal agency has shut the program down for some unbelievable reasons. You just have to read his column and then come back here.

Gawande pulls few punches in setting up the piece:

“In Bethesda, Md., in a squat building off a suburban parkway, sits a small federal agency called the Office for Human Research Protections. Its aim is to protect people. But lately you have to wonder.”

I learned about this New Year's Eve and I tried to not let it ruin my holiday, nor did I want to start the blogging year on such a negative note. It must be incredibly frustrating for the people who have been working on this initiative — to be making such great progress with a method that is repeatable and transferable to other hospitals and to forced to shut it down. Will the government pay for the care of patients who get infections as a result???

Maybe the fault in the Johns Hopkins program was that they purposefully set up this medical research structure of “we're using checklists for these patients and NOT using them for these… let's compare the results.” That seems to be the tradition in medical research… it seems to be a bit different than the Lean notion of kaizen, don't you think? With kaizen, we would start with checklists in a small area, pilot to see the results, and then, given that it works, spread it to other areas as quickly as possible. Would the government see that any differently? I'd have to think you can't pilot changes in a small area first… but then again, if something works, why wait? To that end, why is the government not using its muscle to insist that EVERY hospital use the checklists method instead of slapping those who are, partly because it might make some doctors look bad?

Argh, there's more I want to write, but I need to step away from the keyboard and calm down again. This really worries me, the impact this might have on Lean methods and other process improvements that are going on in hospitals. I'd hate to think people would get scared and think it's safer or better to do nothing… the government doesn't seem to care if you do nothing to improve hand hygiene and prevent infections.

Gawande summarizes some of the history of healthcare quality improvement:

Scientific research regulations had previously exempted efforts to improve medical quality and public health â€” because they hadn't been scientific. Now that the work is becoming more systematic (and effective), the authorities have stepped in. And they're in danger of putting ethics bureaucracy in the way of actual ethical medical care. The agency should allow this research to continue unencumbered. If it won't, then Congress will have to.

Ah the irony, as improvement becomes more “scientific,” it somehow becomes more threatening to the feds. As I'm going through final editing of my book, this is really making me wonder about how “Standardized Work” and “kaizen” are really going to be implemented more widely in this industry. Maybe the hospitals who have done well so far should be lucky to have been “under the radar” if you will? Maybe we need less promotion of Lean and more action. What the bureaucrats don't know can't hurt them… but them taking action on stuff they know little about… that hurts patients.

I think you definitely need to take a step back from the keyboard for a bit, you are essentially advocating unethical and unsupervised tests on patients if they “get results.”

The annals of medical history, even within the 20th century, are riddled with exploitative and harmful experiments. If they weren’t, the Office for Human Research Protection wouldn’t exist.

Yes, the Michigan program is a brilliant expirement, and one that should be continued…Legally and ethically.

To get rid of the monitors, as apparently Pronovost did, is to put the entire well-being of a patient into a hidden, biased, singular invidivual. Hardly the “scientific” standard Pronovost and Gawande both claim they were moving towards.

In this specific case, you can argue that the results justify the means. Except that doesn’t work when you put millions of people’s lives in the hands of thousands of individuals with their own internal biases and predilections.

The checklist was about creating standards, not circumventing them.

It’s rather comical that your anger here stems from a man’s inability to follow the very thing he was championing – Standard Work.The Michigan expirement failed to do the standardized procedure every undergraduate researcher learns.

Getting a BA in most fields requires learning to deal with an IRB and also why it’s necessary.

J – you raise some good points. I guess part of the dispute is about the definition of “research.” Is this “unethical and unsupervised tests” or is it quality improvement that Gawande insisted had normally been exempted from those protections.

I understand the need for such protections, but is it appropriate in this case?

One thing I’m guilty of is popping off without first asking more questions for understanding.

Did Provost violate the Standardized Work (ironic, you’re right) or is it a matter of different interpretations of the Standardized Work?

If there’s not a “clear and unambiguous standard,” hopefully the feds will provide clarification on HOW to perform kaizen and to implement new methods like this in hospitals.

J Thatcher – I missed the part about where Dr. Provenost modified his approach… what article is that from? I thought the other hospitals were doing exactly what had been done at Hopkins and the feds had just learned of it? Maybe it makes no difference in your view if he “got rid of monitors” or “never had monitors in place, because they weren’t necessary.”

This was a doctor doing good work, not some Nazi. This is hardly “millions of lives” in the hands of reckless individuals…. that’s a comical leap of your own there. What is that statement based on?

“The Office was unimpressed by thefact that the study was approved by two institutional review boards or that the information collected was not sensitive and was well protected. It also did not care that the checklist could have been implemented without consent if Pronovost had not tried tomonitor the results.”

So there’s the think that really gets me… experimenting would have been OK as long as he wasn’t gathering data. How do you do scientific improvement, PDCA, or DMAIC without measuring results?

The journal (written by a lawyer) continues:

“In the checklist study,there were no risks to the patients since using the checklist had no side effects and inessence ensured they got the care they should have been getting anyway”

and

“How many people would believetheir doctors should ask their consent before using a piece of paper that reminds them towash their hands and use sterile dressings? It is hard to see who is being protected fromwhat, other than the general public from realizing exactly how common preventable lineinfections really are.”

First off, I’m not a medical specialist, my graduate work was in something very different but still on human subjects. So from a standards’ point of view, I’ve done the whole rigmarole, but it could very well be a different one.

Interesting point on how to implement kaizen in a medical environment.

I think we may be getting at some very important here – is kaizen suited, de facto, for a hospital?

Clearly it benefits hospitals. Clearly it benefits most things.But that doesn’t necessarily mean that it can just be plopped down in an hospital.

Medicine is difficult, people’s lives hang in the balance. And like it or not a history of poorly made decisions (by patients, doctors, legislators, etc.) has left us with a very specific means of going about the improvement of health treatment.

As much as I adore Hugh Laurie, if doctors actually behaved like House their careers would end sooner than Black Adder – The Cavalier Years.

So a system exists by which medical experiments may be run – this is predominantly used for drugs/surgeries but the governing body seems to feel a checklist qualifies as well.

This system is not designed for a process of continual gradual improvement but rather a series of defined, tested, approved steps.

How do we reconcile one with the other?

One possibility I see is by essentially viewing each medical “experiment” by government definition (with all its required protections and forms) as a kaizen “step.”

This makes the “continual” hard as there is a lag time for both initial approval and final approval to finalize and enact the process in general. That said, multiple tests can be run at once – a lab manager I once had the pleasure of knowing would often be running four to five overlapping studies at a time – and this could minimize the lag, increase delivery across the board, and give some semblance of “continual, small improvements.”

anonymous – it doesn’t matter that *this* doctor isn’t a “nazi,” by the way, your comparison causes you to automatically lose any internet argument (it’s well documented), but rather that he could be. Removing a monitor allows for complete trust to be placed into an individual, in this case one who appears to deserve it.

But that doesn’t mean that every one does, and that does mean that we all have to follow directions when lives are at stake.

And yes, I would say that nationally the health care industry does have “millions of lives” in its hands. These policies are national ones, that have to be followed by everyone… nationally.

Mark-Good find. Wow.It does look like the feds screwed this one up.If he had two full review boards, there’s really nothing more an individual can do.

I was (honestly) more thinking of the things like the 1000s of African Americans subjected to various tests without their knowledge in the U.S., the widespread practice of lobotomies on mental patients in the early 20th century, etc.Maybe a website like – http://www.rbs2.com/humres.htmmight help.

Most of my (academic) research was done on “at risk” populations so the history of “consent” is something I’ve been forced to digest many a time.

But, back on issue, I do think this raises the interesting issue of how you create an atmosphere of “continual small improvements” in the midst of a large, regulated system that requires massive lag time before beginning any testing.

I think this raises some very interesting questions about improvement methods in the medical profession and elsewhere.

On the one hand, applying simple, proven quality tools like a checklist should be a no-brainer, as should replacing checklists with more sophisticate fail-safe or error-proofed systems.

On the other hand, the history of medical ethics teaches us to look closely at the total effect of any change; to treat medical treatment as a system.

If I have read the Office for human Research Protection’s objections correctly, they are concerned (in more bureaucratic terms) with the total change in outcomes; not merely the reduction in error rates. I think it is rare for companies implementing quality improvements (not just Lean) to take such a systemic view of the impact of small, incremental improvements.

How often is the impact of kaizen evaluated at the level of the corporate balance sheet?

I’m a manufacturing guy…so I find myself baffled at all this. When we develop checklists for standard work, the intent is usually merely to insure that the current standard gets followed. The only pushback on this is usually the usual printing issue to insure there is always a supply of forms, and also some concern that filling the checklist may take extra time.

I have to believe that there are teams in hospitals all over the country that are developing checklists every day, again for the purpose that each patient gets “best practice”…that the standard is always applied. The success criteria is probably a before and after kind of comparison. This hardly seems like a medical experiment, but rather a daily effort at improving quality.

It seems like nobody was subjected to a doctor intentionally not washing their hands, or not donning a sterile gown. That would clearly be an ethical problem. In this case, they were just trying to improve adherence to a standard, and the results were outstanding. Is the government saying nobody should improve quality?

Seems like they are encouraging people to hide their problems by saying that by separating experimental cells (Docs that follow the standard vs. one’s that forgot to) is an ethical problem. Its easier to just assume…”of course everyone follows the standard”. Granted I wouldn’t want to be the patient in the “forgot” column, but I would certainly want to know that a “forgot” column exists, and everyone’s trying to eliminate it.

“The results were stunning. Within three months, the rate of bloodstream infections from these I.V. lines fell by two-thirds. The average I.C.U. cut its infection rate from 4 percent to zero. Over 18 months, the program saved more than 1,500 lives and nearly $200 million.”

Here, in this nation, there is a person or group of persons who just put to death 1000 innocent people per year seeking care in a hospital.

Does this also mean that a patient with a checklist will not have their wishes followed?

I think the checklists do fit the definition of “standardized work” since they:

1) are specific about tasks and sequence2) defines the best way of doing the work3) are used to guide the work as it is done

So I think it’s more than documentation – making sure a task got gone. This is about making sure tasks got done the right way. Effort went into determining the best method.

Does their approach perfectly follow the Toyota or Training Within Industry models? Probably not (I don’t know, I haven’t seen the checklists first hand). The checklists are written by doctors, which is a good sign (being done by those who do the work). Does the checklist explain “key points” of “why” certain things need to be done? Probably not… but that would be a nice use of the Toyota method.

[…] my original blog post about the use of checklists at Johns Hopkins and the follow up about the government putting a stop to the program. “We do not want to stand in the way of quality improvement activities that pose minimal risks to […]